Form Fda 3486 – Fill Out and Use This PDF

Form FDA 3486 is an integral document within a company's record keeping system. It serves as a way to protect any current or past equipment registrations, product listings, and other key information. Additionally, Form FDA 3486 supplies the proper authorization to financially instigate inspections and approve fees associated with such task. Overseeing organizations are given complete access to review this form for anything amiss and attribute further consequences upon discovering any discrepancies. Essentially, Form FDA 3486 makes sure standard protocol is observed in combination with food safety measures at mandated commercial sites.

Get Form Now Download PDF

Form Fda 3486 PDF Details

Everyday, people all over the world make products that they hope will be successful. Whether it is a new cookie recipe or a new toy, these people put their heart and soul into their work in the hopes of making something that will bring them success. In order to ensure that these products are safe for consumers, the creators often send them to the Food and Drug Administration for inspection. The FDA has a process for inspecting these products called form FDA 3486. This process is important to ensure the safety of all consumers.

Question	Answer
Form Name	Form Fda 3486
Form Length	8 pages
Fillable?	No
Fillable fields	0
Avg. time to fill out	2 min
Other names	form3486, bpdr form 3486, fda form 3486 instructions, fda form 3486

12

Form Preview Example

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FDA USE ONLY

FOOD AND DRUG ADMINISTRATION

Date Received:

BIOLOGICAL PRODUCT DEVIATION REPORT

Date Reviewed:

BPD ID:

* Indicates required information

BPD No.

A. FACILITY INFORMATION

B. BIOLOGICAL PRODUCT DEVIATION (BPD) INFORMATION

1. Reporting Establishment Information

1.

Establishment Tracking #

* Reporting Establishment Name

2.

Date BPD Occurred

3. * Date BPD Discovered

* Street Address Line 1

4. * Date BPD Reported

Street Address Line 2

5. * Description of BPD (use Page 2 for additional space)

* City

* State

Country

* Zip Code

* Point of Contact

* Telephone #

6. * Description of Contributing Factors or Root Cause

(use Page 3 for additional space)

E-mail

2. * Reporting Establishment Identification Number

FDA Registration #

CLIA #

7. * Follow-Up (use Page 4 for additional space)

3. If the BPD occurred somewhere other than the above

facility, please complete this Section and Section A4;

otherwise, continue on to Section B1.

* Establishment Name

Street Address Line 1

8. * Please Enter the 6 Character BPD Code

Street Address Line 2

* City

* State

C. UNIT / PRODUCT INFORMATION

* Country

Zip Code

4. Establishment Identification Number

Please check the type

Blood

(Continued on Page 5)

of product:

FDA Registration #

Non-Blood

(Continued on Page 6)

CLIA #

FORM FDA 3486 (10/12)	Form Approved:	Page 1 of 8
	OMB No. 0910-0458	Page 1 of 8
	OMB No. 0910-0458
	Expires: 1/31/2014

PSC Publishing Services (301) 443-6740 EF

See PRA Statement on Page 8.

Biological Product Deviation Report

B5. DESCRIPTION OF BPD (CONTINUED)

FORM FDA 3486 (10/12)	Page 2 of 8

Biological Product Deviation Report

B6. DESCRIPTION OF CONTRIBUTING FACTORS OR ROOT CAUSE (CONTINUED)

FORM FDA 3486 (10/12)	Page 3 of 8

Biological Product Deviation Report

B7. FOLLOW-UP (CONTINUED)

FORM FDA 3486 (10/12)	Page 4 of 8

Biological Product Deviation Report

C1. BLOOD PRODUCTS / COMPONENTS

TOTAL NUMBER OF UNITS:

	Unit #	Collection Date	Expiration Date	Product Code	Disposition	Notification
	Unit #	(MM/DD/YYYY)	(MM/DD/YYYY)	Product Code	Disposition	(Y,N,RN)
		(MM/DD/YYYY)	(MM/DD/YYYY)			(Y,N,RN)

	1.)

	2.)

	3.)

	4.)

	5.)

	6.)

	7.)

	8.)

	9.)

	10.)

	11.)

	12.)

	13.)

	14.)

	15.)

	16.)

	17.)

	18.)

FORM FDA 3486 (10/12)	Page 5 of 8

Biological Product Deviation Report

C2. NON-BLOOD PRODUCTS

TOTAL NUMBER OF LOTS:

	Lot #	Expiration Date	Product Type	Product Code	Disposition	Notification
	Lot #	(MM/DD/YYYY)	Product Type	Product Code	Disposition	(Y,N)
		(MM/DD/YYYY)				(Y,N)

	1.)

	2.)

	3.)

	4.)

	5.)

	6.)

	7.)

	8.)

	9.)

	10.)

	11.)

	12.)

	13.)

	14.)

	15.)

	16.)

	17.)

	18.)

FORM FDA 3486 (10/12)	Page 6 of 8

Biological Product Deviation Report

D.ADDITIONAL COMMENTS

FORM FDA 3486 (10/12)	Page 7 of 8

Biological product deviation reports required by 21 CFR 600.14, 21 CFR 606.171, or 21 CFR 1271.350(b), involving products regulated by the Center for Biologics Evaluation and Research (CBER), mail to:

Director, Office of Compliance and Biologics Quality (HFM-600) Center for Biologics Evaluation and Research

Food and Drug Administration

1401 Rockville Pike, Suite 200N Rockville, MD 20852-1448

Biological product deviation reports required by 21 CFR 600.14, involving licensed biological products regulated by the Center for Drug Evaluation and Research (CDER), mail to:

Division of Compliance Risk Management and Surveillance Office of Compliance

Center for Drug Evaluation and Research Food and Drug Administration

10903 New Hampshire Ave.

Silver Spring, MD 20993-0002

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 2 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

FORM FDA 3486 (10/12)	Page 8 of 8

How to Edit Form Fda 3486 Online for Free

bpdr form 3486 can be filled in online easily. Just try FormsPal PDF tool to get the job done without delay. To have our editor on the leading edge of convenience, we strive to put into operation user-oriented capabilities and improvements regularly. We're always grateful for any feedback - help us with revampimg PDF editing. Here is what you would want to do to start:

Step 1: Access the form inside our editor by pressing the "Get Form Button" above on this page.

Step 2: Once you access the online editor, you will see the document all set to be completed. Besides filling in various blanks, you may also do other things with the form, that is putting on custom textual content, editing the initial text, adding graphics, placing your signature to the form, and more.

In order to complete this PDF form, be certain to enter the information you need in each blank:

1. It is advisable to complete the bpdr form 3486 properly, thus be attentive when filling in the areas containing all these blank fields:

fda form 3486 instructions writing process detailed (part 1)

2. Soon after the last part is filled out, go on to enter the suitable information in all these: Telephone, Email, Reporting Establishment, FDA Registration, CLIA, If the BPD occurred somewhere, Description of Contributing, FollowUp use Page for additional, Establishment Name, Street Address Line, Street Address Line, City, Country, Please Enter the Character BPD, and State.

fda form 3486 instructions writing process detailed (stage 2)

3. Completing FDA Registration, CLIA, FORM FDA, Please check the type, Blood, Continued on Page, of product, NonBlood, Continued on Page, Form Approved OMB No Expires, See PRA Statement on Page, Page of, and PSC Publishing Services is essential for the next step, make sure to fill them out in their entirety. Don't miss any details!

Continued on Page, FORM FDA, and NonBlood of fda form 3486 instructions

Always be extremely attentive when filling out Continued on Page and FORM FDA, since this is the part where a lot of people make mistakes.

4. It's time to fill out this fourth section! Here you'll get all these B DESCRIPTION OF BPD continued empty form fields to do.

The best ways to prepare fda form 3486 instructions stage 4

5. The very last step to submit this PDF form is critical. Make sure that you fill out the mandatory blank fields, including B DESCRIPTION OF CONTRIBUTING, prior to using the file. Neglecting to do so could produce an incomplete and potentially nonvalid document!

B DESCRIPTION OF CONTRIBUTING, B DESCRIPTION OF CONTRIBUTING, and B DESCRIPTION OF CONTRIBUTING inside fda form 3486 instructions

Step 3: Be certain that the information is right and press "Done" to proceed further. Go for a free trial subscription at FormsPal and get immediate access to bpdr form 3486 - download or modify inside your personal account. FormsPal guarantees protected document completion devoid of personal information record-keeping or sharing. Feel comfortable knowing that your details are in good hands with us!

Form Fda 3486 isn’t the one you’re looking for?